Director Operations Clinical Data Management

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Job Title:

Director Operations - Clinical Data-Management (CDM)

Division / Function:

Data Management Standards & Systems / Clinical Development Operations

Location:

Paris (FR) London (UK) or Boston (US)

WHAT - Summary & Purpose of the Position

The Director Operations - Clinical Data-Management is responsible for the management of critical trial and non-trial specific activities and functions that support the Clinical Data Management organization.

He/She is responsible for leading the development of and oversight of administrative and trial and non-trial operations to help ensure Ipsen and Ipsen CDM meet or exceed Ipsen goals and objectives maintain regulatory compliance and effectively work with strategic partners.

He/She is an integral part of the CDM leadership team helping define and execute near and longer term strategies in collaboration with CDM and Ipsen leadership.

WHAT - Main Responsibilities & Technical Competencies

• Non-trial administrative operations responsibilities

• Define implement and oversee Quality Management (QM) within CDM. This includes but is not limited to:
  • Creating and implementing a QM framework in CDM that defines quality goals processes and KQIs;
  • Working collaboratively with Quality Assurance (QA) so that the QM framework works harmoniously and efficiently with QA processes and procedures;
  • Working with QA and CDM Operations to ensure quality findings CAPAs audit or inspection reports or findings or other quality-related actions are completed on time;
  • Ensuring CDM-related documents are appropriately filed in the Trial Master File (TMF) by collaborating with QA Ipsen CDM and external partners.
• Works collaboratively with Asset Data Management leaders Talent Acquisition (TA) and external vendors and partners to identify and secure personnel resources. This includes but is not limited to:
  • Creating and managing a resourcing requirement model or tool that evaluates needs on an ongoing basis;
  • Establishing a process to secure the right people at the right time and communicating status of the resourcing requests to stakeholders;
  • Devising a mechanism to manage peaks and troughs in resourcing needs to ensure deliverables are met.
• Manages the CDM documentation environment such as Standard Operating Procedures (SOPs) and other working guidelines procedures and processes. This includes but is not limited to:
  • Ensuring the correct SOPs etc. are in place to meet regulatory requirements while providing guidance to CDM staff and partners on how to conduct Ipsen CDM trials;
  • Periodic review and revision of CDM documentation;
  • Distribution training and oversight of training compliance with SOPs etc. as they are developed or revised;
  • Creating implementing and overseeing a model to evaluate SOP compliance by CDM staff through methods such as review of training records periodic assessments or audits and trial-specific / team-specific / vendor-specific spot checks.

• Direct change management activities within CDM. This includes but is not limited to:
  • Establishing a change management methodology to be used within CDM including strategy framework project management of initiatives measurement of status and success and communications;
  • Promoting and advocating a change management mindset across CDM;
  • Developing and leading change management initiatives and projects as defined by the CDM leadership team whether they are driven by cultural process technical or other origin;
  • Working collaboratively and effectively with broader change management leaders at Ipsen;
  • Participating in and aligning with broader Ipsen change management initiatives as necessary;
  • Collaborating with partners to leverage their expertise and support with Ipsen CDM change management initiatives.
• Participate in operational governance with external partners. This includes but is not limited to:
  • Working directly with partners on initiatives such as change management resourcing process changes; innovation KPIs/KQIs/metrics etc. as assigned;
  • Participating in operational governance meetings and executive governance meetings as requested.
• Track manage and report on CDM KPIs KQIs and other metrics. This includes but is not limited to:
  • Establishing and overseeing a strategy on which metrics to collect target setting collation methodology reporting frequency and distribution and result analysis and action planning;
  • Working collaboratively with internal CDM internal Ipsen and external partners to gather data;
  • Analysing and reporting outcomes to stakeholders;
  • Defining and executing action plans based on outcomes.
• Contribute to innovation initiatives as requested. This includes but is not limited to:
  • Working collaboratively with Ipsen CDM leadership and external partners to strategize on innovation;
  • Participating in innovation initiatives as directed which may include but not limited to:
    • Project management
    • Change management
    • Process changes documentation changes training and adoption oversight
    • KPI KQI metrics and ROI tracking
    • Aligning with broader Ipsen innovation initiatives potentially including representing Ipsen CDM
• Manage Ipsen CDM training environment. This includes but is not limited to:
  • Collaborating with Ipsen CDM leadership to define CDM training framework;
  • Working with QA and other Ipsen functions to align CDM training with Ipsen standards;
  • Oversight of and reporting on internal Ipsen CDM and external partner training compliance;
  • Collaborating with internal stakeholders and external partners to identify new training needs due to new or revised regulations changes in technology processes or operating model etc.;
  • Identifying methods to improve delivery and comprehension of training materials.
• Other administrative operational assignments as requested.

• Trial / Study-related responsibilities

• Direct management of Ipsen CDM resources that are pooled across therapeutic areas including coding and data cleaning when that work is done in-house by Ipsen CDM.
• Ensure study timelines and deliverables are met by team members with quality.
• Work collaboratively with Ipsen CDM leadership to ensure appropriate resourcing study expectations deliverables and timelines are understood and achieved.

• Leadership / Management

• Responsible for the recruitment talent development line management and supervision of team members in his/her team including objectives definition appraisal review and performance management.
• Responsible for building capabilities and technical skills within his/her group to ensure effective high-quality delivery.
• Member of the Ipsen CDM Leadership team successfully participating and executing responsibilities as assigned by the Ipsen Head of DMSS.

HOW - Behavioural Competencies Required

Purpose Dedication
Safeguards data integrity and patient safety. Ensures decisions and data strategies support ethical conduct regulatory reliability and inspection readiness. Promotes a consistent quality and compliance culture across internal teams and vendors.

Thinking Dexterity
Connects study execution to asset and submission strategy. Anticipates risks affecting timelines standards and data flow and implements mitigation plans. Uses metrics and trend analysis to improve data quality efficiency and processes while introducing appropriate innovation and technology.

Social Agility
Collaborates effectively across Clinical Operations Biostatistics Programming Regulatory and external partners. Influences in a matrix environment manages challenging discussions constructively and adapts communication to technical and non-technical stakeholders.

Growing Self and Others
Leads coaches and develops Data Management staff. Sets clear expectations provides feedback and builds team capability in standards quality oversight and vendor management. Encourages ownership learning and knowledge sharing.

Being Intentional
Operates effectively in ambiguity and changing development environments. Communicates decisions clearly explains trade-offs and escalates risks when needed. Maintains focus and resilience under delivery pressure.

Making Real Impact
Delivers reliable inspection-ready databases on time and within budget. Holds teams and vendors accountable to performance standards. Drives continuous improvement and contributes clear data-based recommendations to program and submission decisions.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Ability to manage large projects: plan activities and tasks identify project constraints and dependencies identify and mitigate risks report on project status produce progress metrics and communicate efficiently with external vendors as well as internal stakeholders
• Ability to produce high quality accurate work to meet deadlines
• Ability to interact satisfactorily with staff of differing disciplines
• Ability to work across organizational lines and geographies
• Well-developed time management communication presentation analytical and interpersonal skills
• Responsible flexible and accountable with a pro-active approach
• Experience of managing and developing relationships with Service Providers
• A good understanding of the drug development process
• Approximately 5-7 years of experience in a CDM leadership position with proven Project Management skills in Data Management activities at a development program level

Knowledge & Experience (preferred):

• High knowledge of international standards (ICH GCP CDISC ) and regulations related to clinical studies and data management
• Technical expertise in CDM systems
• Formal change management experience or certification
• Experience working across cultures and geographies
• Good budget management understanding

Education / Certifications (essential):

• Life Science and/or Information Technology graduate

Language(s) (essential):

• English

Language(s) (preferred):

• French

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